Assessing Physical Fitness in Cancer Patients With Cardiopulmonary Exercise Testing and Wearable Data Generation
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | February 2016 |
| End Date: | February 2018 |
The primary objective of this study is to assess the feasibility of a multi-institutional
study that collects cardiopulmonary exercise testing and 6 minute walk distance performance
testing prior to a cycle of chemotherapy (or transplant), followed by collection of patient
generated health data (wearable activity monitors and patient reported outcomes) for the
subsequent month. In addition to demonstrating feasibility, the study looks to generate
preliminary data that supports the capacity of physical performance testing and
patient-generated health data to complement clinician-rated performance status in patients
receiving chemotherapy.
study that collects cardiopulmonary exercise testing and 6 minute walk distance performance
testing prior to a cycle of chemotherapy (or transplant), followed by collection of patient
generated health data (wearable activity monitors and patient reported outcomes) for the
subsequent month. In addition to demonstrating feasibility, the study looks to generate
preliminary data that supports the capacity of physical performance testing and
patient-generated health data to complement clinician-rated performance status in patients
receiving chemotherapy.
Physical fitness, based on tests of physical performance and measurements of daily activity,
can serve as both a risk stratification variable and clinical outcome for patients prior to
or during cytotoxic chemotherapy. Many cytotoxic therapies cause premature aging and frailty
in a sizable portion of patients, so measuring and improving physical function may also limit
late morbidity and mortality in certain patient populations. Clinician-rated performance
status (cPS; e.g., ECOG or Karnofsky PS) in addition to organ-specific function have been
used to prognosticate risk and determine treatment strategy, but cPS only readily identifies
individuals with significant functional compromise. Objective evaluations of physical
function, such as aerobic capacity and measured daily activity, may have greater potential to
improve the precision of performance status evaluation.
can serve as both a risk stratification variable and clinical outcome for patients prior to
or during cytotoxic chemotherapy. Many cytotoxic therapies cause premature aging and frailty
in a sizable portion of patients, so measuring and improving physical function may also limit
late morbidity and mortality in certain patient populations. Clinician-rated performance
status (cPS; e.g., ECOG or Karnofsky PS) in addition to organ-specific function have been
used to prognosticate risk and determine treatment strategy, but cPS only readily identifies
individuals with significant functional compromise. Objective evaluations of physical
function, such as aerobic capacity and measured daily activity, may have greater potential to
improve the precision of performance status evaluation.
Inclusion Criteria:
- Patients with solid tumor or hematologic malignancies who are planning to receive a
cycle of cytotoxic chemotherapy or patients who are planning to receive stem cell
transplant.
- Age ≥ 18
- At least 6 weeks out from surgical resection
- Presence of working email address
- Access to internet at home and access to electronic device(s) capable of charging and
syncing the Fitbit
- Ability to read and understand English
- Ability to understand and comply with study procedures including wearing Fitbit for
the entire length of the study
- Approval of attending oncologist for participation in the study
- Hb ≥ 8 g/dL (most recent lab draw)
- Willingness and ability to provide written informed consent
Exclusion Criteria:
- Dementia, altered mental status, or psychiatric condition that would prohibit the
understanding or rendering of informed consent
- Presence of cardiac disease including acute MI within past 6 weeks, unstable angina,
uncontrolled arrhythmias causing symptoms, active endocarditis, myocarditis, or
pericarditis,symptomatic aortic stenosis, uncontrolled heart failure, syncope in the
past 6 weeks, severe untreated hypertension at rest (>180 mmHg systolic, >100 mmHg
diastolic)
- Acute pulmonary embolism or thrombosis of lower extremities in the past 6 weeks
- Uncontrolled asthma
- Pulmonary edema
- Suspected dissecting aneurysm
- Room air desaturation at rest
- Respiratory failure
- Acute noncardiopulmonary disorder that may be aggravated by exercise
- Mental impairment leading to inability to cooperate with instructions
- Orthopedic impairment that compromises exercise performance
We found this trial at
1
site
Click here to add this to my saved trials
